MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CLXUSA

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Noise, Audible (3273)

Patient Problem Blood Loss (2597)

Event Date 06/28/2016

Event Type  malfunction  

Event Description

Patient was connected to the extracorporeal photopheresis kit on the therakos cellex machine.The procedure was started at 1350.A loud noise was heard at 1400.The machine was immediately shut off.Blood began leaking out of the centrifuge section of the machine.The patient was assessed by the md.It is estimated that the patient lost approximately 160ml of blood.It appeared that the centrifuge bowl exploded.We have photos of the event but cannot find a place to attach them in this report.Manufacturer response for extracorporeal photopheresis machine, therakos cellex (per site reporter): the following quoted information is the manufacturer's response."based on the complaint description and review of the smartcard data, it appears that the leak occurred at one of the pressure domes due to the pressure dome popping off of the kit while installed on the instrument.A system pressure alarm and a return pressure warning occurred after processing 206ml of whole blood, early in the treatment, which indicates that the instrument alarmed per specification.The results of the visual examination of the photos provided and the returned kit indicated the diaphragm of this pressure dome was not completely seated on one side and the foot of one of the 2 latches was bent outward.It appears that the diaphragm was pushed down where it was unseated on the instrument, which is not per operator's instructions.The combination of these facts leads us to believe that there was a problem during installation and thus resulting in issues at the beginning of the treatment." why didn't the pressure alarm go off during pressure testing: "the pressure testing that occurs during the prime phase is an extremely low pressure test (~10 mmhg) which primarily verifies the calibration of the pressure sensor in the instrument pump deck.The sensor met its calibration requirements and the dome was seated enough to withstand the low pressure test.Therefore, no alarm was triggered during this test." does the ecp machine have a qc alarm that senses that the pressure dome is seated properly, if so why did it not go off before the run started: "the current operating software on the cellex instrument has no test that specifically verifies a pressure dome is correctly installed.The pressure sensor calibration test mentioned in the question above is not able to alert an operator to an improperly installed pressure dome." the machine was processing before the alarm was triggered."the pressure threshold was reached in the return line which triggered the alarm #17: return pressure alarm.Because the pressure dome diaphragm in question did not have enough resistance from the pressure sensor during the high pressure experienced, the dome lifted off of the sensor and the diaphragm unseated from the dome resulting in a blood leak.The diaphragm unseating (and pressure data from the smartcard) lead us to the most likely failure mode of an improperly seated dome." the machine passed qc and a 2 person check."can't comment on protocol as we are not familiar with the specifics of this check.However, based on experience, if a diaphragm is unseated as this one was and there are no obvious defects on the body of the received pressure dome, it suggests that one of the latches of the pressure dome was not fully seated in the circumferential groove in the sensor.Although the operator believed the dome was properly seated, it appears that it must not have been.There is no specific sensor on the instrument that verifies proper dome seatment.".

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; west chester PA 19380
• MDR Report Key: 6154347
• MDR Text Key: 61784790
• Report Number: 6154347
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2018
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Other Device ID Number: THERAKOS PHOSOPHERESIS PROCED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 69 YR
• Patient Weight: 71